Senior Engineer, Manufacturing

Enable Injections Inc.•Sharonville, OH

31d•Onsite

About The Position

This role focuses on manufacturing equipment specification, design, development, construction, implementation, or modification. The engineer will troubleshoot and implement solutions to aid in product manufacturing, often involving changes to assembly equipment, part/mold design, or inspection criteria to enhance quality, reproducibility, efficiency, or safety. The position also involves assisting with equipment qualification (IQ/OQ/PQ) to meet regulatory requirements, creating and implementing Standard Operating Procedures, and applying engineering principles to solve complex technical challenges. The role includes coordinating with external suppliers and consultants, providing Design for Manufacturability (DFM) and Design for Assembly (DFA) guidance, developing test methods and fixtures, preparing project proposals with cost estimates and schedules, and resolving issues related to manufacturability and product performance. Additionally, the engineer will maintain and repair equipment, delegate tasks, participate in cross-functional teams, provide technical guidance to other engineers, and contribute to project planning and execution. Authoring Quality System documentation is also a key responsibility.

Requirements

Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university; or education/experience equivalent
A minimum of 6 years of manufacturing engineering (equipment/process design and support) in a regulated industry such as Medical Device, Pharmaceutical, or Food; OR a master’s degree in related field plus 4 years’ experience
Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings (Solidworks preferred)
Ability to create experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred)
Strong technical writing skills (planning, protocol writing, execution, report writing, Operating Procedures)
Knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley preferred)
Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ)
Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipment
Strong analytical and creative problem-solving skills, able to provide solutions to complex technical challenges
Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
Communicate effectively through both verbal presentation and technical writing to various internal stakeholders of varying technical abilities
Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
Demonstrated technical coaching and leadership of peers
Strong demonstrated ability to deliver manufacturing projects in a timely manner
Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job
Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities
Solid ability to understand complexity and navigate ambiguity to influence at the department level
Plan and carry out multiple projects concurrently
Ability to analyze problems and troubleshoot solutions
Apply strong cognitive ability to collecting, processing, and disseminating information
Understand current state and dynamics of the business
Ability to foster teamwork, collaboration, negotiation, and influencing others
Consistently open and approachable
Engage colleagues and partners with the Enable Values in mind
Ability to maintain a positive attitude, show empathy for others, and always do the right thing
Ability to understand your own emotions and their effects on your performance
Ability to express your emotions appropriately and have a positive impact on others in support of company goals and a healthy work environment
Excellent time management skills

Nice To Haves

Experience with medical device manufacturing (heat staking, ultrasonic welding, press assembly, adhesives, leak testing) and inspection technologies (vision systems. Pressure decay, flow testing)
Experience programming vision systems, robotics, and PLC
Experience designing and implementing high-volume manufacturing equipment preferred, i.e., production 1M+ annual, cycle time < 3 seconds per process
Six Sigma Yellow/ Green Belt Certification

Responsibilities

Manufacturing equipment specification, design, development, construction, implementation, or modification
Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and/or the modification of part/mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes
Assist in Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements
Standard Operating Procedures creation, revision and implementation including necessary change order, training and qualification activities
Apply engineering principles and methods to understand and provide solutions to complex technical challenges
Identify and coordinate activities with outside suppliers and consultants as required. Interface with and select suitable vendors for the procurement of equipment
Provide DFM and DFA guidance for development of robust product design in collaboration with Product Development
Develop test methods and fixtures to prove functionality of sub-assemblies and final product. Select appropriate test methods and analyze test data to challenge the effectiveness of assembly equipment and processes
Prepare overall project proposals including cost estimates and schedule for designated projects. Assign priority and schedule tasks to provide timely solutions to achieve results
Resolve internal and external (customer or supplier) issues related to manufacturability and performance of product
Maintain and repair equipment
Delegate tasks to technicians and co-ops within the department
Participate in cross functional teams and ideation sessions
Work with functional managers and partners to ensure project goals are met
Provide technical guidance and coaching of other engineers
Contributes to project planning and execution to meet schedule and budget requirements
Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms